ASCO 2020 – New regimen yields better adherence, less toxicity in head and neck SCC


  • Cristina Ferrario — Agenzia Zoe
  • Oncology Conference reports
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Takeaway

  • Weekly cisplatin plus radiotherapy (CDDP+RT) is noninferior to CDDP+RT every 3 weeks (q3w) and has a favorable toxicity profile in postoperative high-risk patients with locally advanced squamous cell carcinoma (SCC) of the head and neck (LA-SCCHN).
  • Authors: weekly CDDP+RT should be the new standard treatment in this setting.

Why this matters

  • CDDP+RT q3w is the standard treatment but raises concerns about toxicity and insufficient adherence.
  • Weekly CDDP+RT could lead to better adherence.

Study design

  • 261 patients were enrolled in the multi-institutional phase 2/3 JCOG1008 trial aimed at testing the noninferiority of the weekly vs q3w regimen in phase 3.
  • Patients were randomly assigned to CDDP+RT 100 mg/m2 q3w (66 Gy/33Fr; n=132) or CDDP+RT 40 mg/m2 weekly (66 Gy/33Fr; n=129).
  • Primary endpoints: proportion of treatment completion (phase 2), and OS (phase 3).

Key results

  • 93.2% in q3w group completed treatment vs 86.8% in weekly group.
  • At a planned second interim analysis in phase 3, the Data and Safety Monitoring Committee recommended terminating the trial because the statistical boundary for OS noninferiority had met the prespecified stopping criteria.
  • 3-year OS:
    • 59.1% in q3w group vs 71.6% in weekly group. 
    • HR, 0.69 (one-sided P for noninferiority=.00272).
  • Better relapse-free survival, better local relapse-free survival, and a favorable safety profile were observed with weekly CDDP+RT.

Funding

  • National Cancer Center.
  • Japan Agency for Medical Research and Development.

Limitation

  • Imbalance in patient characteristics between groups.
  • No adjustments for TNM and human papillomavirus status.

Expert commentary

  • “These results represent a significant achievement,” said Hisham Mehanna, Director, Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, UK. “It is now important to investigate the longer-term toxicity profile and whether there is a superiority of weekly arm with longer follow-up.”